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Advancing development of medicines by academia and non-profit research organizations in the European Union
Providing support for medicine development by academics and clinical researchers is a priority for the European Medicines Agency. The recent launch of free scientific advice to academia and non-profit research organizations developing orphan medicines can help align research with regulatory requirements early during medicine development and enhance the chances of success.
In its 25 years of existence, the European Medicines Agency (EMA) has been collaborating with academics, patients and clinical researchers to foster translation of research into medicines. In view of the increasing engagement of academia in EMA activities, in 2017 a framework for collaboration was introduced to better structure interactions. Here, we summarize some of the key elements of this collaboration and highlight an important step to enhance it: the EMA has completely waived the fees for providing tailored scientific advice to academia and non-profit research organizations developing orphan medicines. The initiative responds to a previous call from academia to address some of the challenges encountered by non-profit organizations developing medicines when navigating the regulatory system in the European Union (EU).
We thank M. Ensini, I. Moulon, J. G. Burgos, J. Llinares and M. Carr for the work on the academia framework.
The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.